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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01843335
Other study ID # 2013/359/REKnord
Secondary ID
Status Terminated
Phase N/A
First received April 26, 2013
Last updated October 29, 2017
Start date September 2014
Est. completion date June 2017

Study information

Verified date October 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- in follow-up after endovascular implantation of abdominal aortic prothesis

Exclusion Criteria:

Study Design


Locations

Country Name City State
Norway St Olavs Hospital Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of endoleak with CEUS Compare CEUS with computed tomography angiography (CTA) sensitivity for detection of endoleak 9 months
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